Table of Contents
- Trials overview
- Cancers studied
- Trial phases and study goals
- Who may be able to join
- What the trials measure
- Key studies in the data
- Patient-friendly terms
Trials overview
The clinical trials in this data are studying Ifinatamab Deruxtecan in people with cancer. The studies are testing it alone and also with other treatments, depending on the trial.[1]
All of the trials listed here are interventional studies, which means participants receive a treatment so researchers can measure the results.[1]
The trials are currently marked Authorised and include studies with different sizes, from small early studies to larger late-stage studies.[1]
Cancers studied
The trials focus on several cancer types, especially small cell lung cancer, non-small cell lung cancer, metastatic prostate cancer, and esophageal squamous cell carcinoma.[1]
Some studies are limited to one cancer type, while others include a broader group of recurrent or metastatic solid tumors such as endometrial cancer, head and neck squamous cell carcinoma, pancreatic ductal adenocarcinoma, colorectal cancer, hepatocellular carcinoma, and others.[1]
This means the research is not limited to one disease area. It is being tested across several advanced cancers to see where it may help most.[1]
Trial phases and study goals
The trials are in Phase 1, Phase 2, and Phase 3.[1]
Phase 1 trials mainly check safety, tolerability, and dose-related problems such as dose-limiting toxicities.[1]
Phase 2 trials look more closely at whether the treatment seems to work, often by measuring objective response or objective response rate.[1]
Phase 3 trials compare Ifinatamab Deruxtecan with standard treatments such as docetaxel, topotecan, or investigator’s choice of chemotherapy, and they focus on outcomes like survival.[1]
Who may be able to join
Most studies are for people with advanced, metastatic, or pretreated cancer, which means the cancer has spread, come back, or already been treated before.[1]
Some trials are focused on people with specific stages, such as stage IV squamous non-small cell lung cancer or pretreated extensive-stage small cell lung cancer.[1]
One study includes people with recurrent or metastatic solid tumors, so the cancer type can vary as long as it fits the study rules.[1]
Each study has its own eligibility rules, so participation depends on the exact cancer type, stage, and prior treatment history.[1]
What the trials measure
A common main result is objective response rate (ORR), which means the percentage of people whose tumors shrink or disappear on scans.[1]
Some studies measure overall survival (OS), which is the time from randomization until death from any cause.[1]
Other studies measure radiographic progression-free survival (rPFS), which looks at how long the cancer does not get worse on imaging tests.[1]
Safety outcomes are also important. These include adverse events, serious adverse events, and whether people stop treatment because of side effects.[1]
Some trials also track special safety checks such as vital signs, lab tests, ECGs, heart scans, eye exams, and ECOG performance status, which is a measure of daily activity level.[1]
Key studies in the data
Several large studies compare Ifinatamab Deruxtecan with standard treatment in late-stage cancer. For example, one Phase 3 study in metastatic castration-resistant prostate cancer compares it with docetaxel and measures overall survival and radiographic progression-free survival.[1]
Another Phase 3 study in relapsed small cell lung cancer compares Ifinatamab Deruxtecan with standard of care and measures objective response rate and overall survival.[1]
A Phase 3 study in pretreated esophageal squamous cell carcinoma compares Ifinatamab Deruxtecan with investigator’s choice of chemotherapy and focuses on overall survival.[1]
There are also Phase 2 studies in non-small cell lung cancer and stage IV squamous non-small cell lung cancer that look at objective response and safety when Ifinatamab Deruxtecan is used alone.[1]
Some early studies test Ifinatamab Deruxtecan in combination with other medicines, such as pembrolizumab, MK-6070, atezolizumab, and carboplatin, to see whether combinations are safe and whether they may improve response.[1]
A broad Phase 1 study also includes many recurrent or metastatic solid tumors and measures objective response rate along with safety endpoints such as DLTs and treatment-emergent adverse events.[1]
Patient-friendly terms
Randomization means participants are placed into treatment groups by chance, not by choice.[1]
Blinded independent central review means scan results are checked by experts who are not part of the treatment team, so the reading is more objective.[1]
RECIST 1.1 is a standard way to measure whether tumors grow, shrink, or stay the same on scans.[1]
Standard of care means the usual treatment used for that cancer outside the study.[1]
Safety lead-in is an early part of a study that helps researchers learn if a treatment combination can be given safely before the main study continues.[1]
